Eisai headquarters in Tokyo (Akio Kon/Bloomberg via Getty Images)
FDA adcomm votes unanimously in favor of full approval for Eisai's new Alzheimer's drug
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee on Friday voted 6-0 in favor of fully approving Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab), which first won an accelerated approval in January.
The full approval, expected on or before July 6, would open the door to wider insurance and Medicare coverage for those with mild cognitive impairment or mild dementia and confirmed presence of amyloid beta pathology but who could not or do not want to pay the $26,500 per year list price.
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